BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL AO REAMER ATTACHMENT 350 RPM

    MDR report key: 3802665 · Received February 25, 2014

    Report

    Report Number
    8031000-2014-00091
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER UNIVERSAL ZO REAMER ATTACHMENT 350 RPM WAS DEFECTIVE. THERE WAS A PROBLEM WITH THE FITTING OF THE AO ATTACHMENT OF DIFFERENT REAMER WITHIN THE AO ADAPTER. THE SURGEON REPORTED THAT THE DETACHMENT FORCE OF THE AO ATTACHMENT FROM THE ADAPTER WAS VERY LOW. THE REAMER DETACHES FROM THE MACHINE VERY EASILY AND OFTEN. THIS ISSUE HAPPENED DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116748 UNIVERSAL AO REAMER ATTACHMENT 350 RPM UNIVERSAL AO REAMER ATTACHMENT 350 RPM GEY ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1